NCT04966936

The Effect of Different Microprocessor Knee Prostheses on Mobility and Gait Parameters in Transfemoral Amputees

The Effect of Different Microprocessor Knee Prostheses on Mobility and Gait Parameters in Unilateral Traumatic Transfemoral Amputees

• Status: Unknown
• Phase: —
• Study type: Observational
• Enrollment: 27 (estimated)
• Sponsor: Gaziler Physical Medicine and Rehabilitation Education and Research Hospital · Academic / Other
• Sex: Male
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

Microprocessor knee joints are prosthetic knee joints with an integrated processor or a computer that can analyze data. During walking, parameters such as step speed, joint angles, and weight transferred through sensors are analyzed by the computer inside the joint and determines the movement for the safest and most normal walking. They have different features from each other in terms of weight/height, sensor and processor frequency, load carrying capacity, phase control (hydraulic, pneumatic, magnetic), battery properties, water resistance, and special activity mode. C-Leg, Genium, Genium X3, Rheo Knee 3, Rheo Knee XC, Orion etc. prostheses of different companies are used as oscillating and compression phase microprocessor knee prostheses. Publications on C-leg, Genium and Genium X3 prostheses are limited in international literature. Although there are existing studies comparing C-leg and Genium, there is no study comparing these three prostheses. The investigators think that our study is important because it is the first study in the literature to compare these three prostheses. In this study, the investigators aimed to examine the effects of different microprocessor knee prostheses on mobility and gait parameters in unilateral traumatic transfemoral amputees.

Detailed description

The study will be carried out with patients who applied to the outpatient clinic or who received inpatient treatment in the orthopedic rehabilitation (amputee) clinic. The patient's demographic information (age, gender, height, weight, body mass index, education level, occupation, marital status) and clinical characteristics (amputation date, cause of injury, amputation side, etc.) will be recorded with the evaluation to be made to the patient. The activity levels of the patients will be evaluated by the Amputee Mobility Predictor, the mobility of the patients by the Locomotor Capacity Index, the prosthesis satisfaction in general with the visual analog scale (VAS), the walking ability and capacity with the prosthesis will be evaluated by the 2 min walking test, and the gait analysis will be evaluated in the motion analysis laboratory.

Conditions

• Amputation

Interventions

Type	Name	Description
OTHER	questionnaires for clinical assessments	Amputee Mobility Predictor, Locomotor Capacity Index, visual analog scale (VAS)
OTHER	2 minute walking test	the individual is asked to walk in his natural course within 2 minutes on a track whose distance is measured beforehand, and at the end of two minutes, the distance he walks will be recorded in meters (m).
OTHER	The gait analysis at the motion analysis laboratory.	Temporo-spatial parameters (gait speed (m/s), cadence (step/s), other foot contact (%), double support time (second), single support time (second), stance phase time (sec), swing phase time (sec), stride length (meters)) and kinematic parameters (hip, knee, ankle joint angles (frontal, sagittal, transverse plane), maximum knee flexion angles in the stance and swing phase, velocity-dependent maximum knee flexion angles in the swing phase, knee flexion moments will be compared

Timeline

• Start date: 2021-07-01
• Primary completion: 2022-07-01
• Completion: 2022-08-01
• First posted: 2021-07-19
• Last updated: 2021-07-19

Locations

1 site across 1 country: Turkey (Türkiye)